A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

Stopped early · Phase 1/Phase 2

Conditions studied: Anaplastic Thyroid Cancer

In brief

The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment will continue until disease progression or the development of intolerable toxicities.

Key facts

Study ID

NCT00603941

Run by

Daiichi Sankyo

People needed

19

Starts

2008-01-01

Expected to finish

2011-12-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically diagnosed, advanced ATC
• Measurable lesion(s)
• Lesion(s) (primary or metastatic) with viable tumor tissue accessible for repeated biopsy
• Age equal to or older than 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Adequate organ and bone marrow function
• Agreement to use effective contraception while on treatment and for equal to or greater than 3 months after end of treatment
• Pregnant or breastfeeding

You may not qualify if…

• Medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease.
• Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
• Clinically significant active infection requiring antibiotic or antiretroviral therapy
• Concomitant use of other thiazolidinediones (TZDs)

Where it is running

• Univ of Colorado Cancer Center — Aurora, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University, Siteman Cancer Center — St Louis, Missouri, United States
• Ohio State Univ — Columbus, Ohio, United States
• Oregon Health Science Univ — Portland, Oregon, United States
• University of Pennsylvania Maloney Hospital — Philadelphia, Pennsylvania, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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